Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before you start using MAXALT Wafers. This leaflet answers some common questions about MAXALT Wafers. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MAXALT Wafers against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What MAXALT Wafers are used for

MAXALT Wafers are used to relieve the headache pain and other symptoms of migraine attacks. MAXALT Wafers do not work for other types of headaches.

Migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. Some people may have visual symptoms before the headache, called an aura. An aura can include flashing lights or wavy lines.

Migraine attacks last anything from two hours to two days and they can return frequently. The severity and frequency of migraine attacks may vary.

Migraine occurs in about one out of every 10 people. It is three times more common in women than men.

Six out of ten migraine sufferers have their first attack before the age of 20.

There is no single cause of migraine. It tends to run in families. Certain things, singly or in combination, can trigger migraine attacks in some people. Some of these triggers are:

• certain foods or drinks, for example, cheese and other dairy products, chocolate, citrus fruit, caffeine, alcohol (especially red wine)
• stress, anger, worry
• changes in routine, for example, under or over sleeping, missing a meal, change in diet
• bright light or loud noises
• hormonal changes in women, for example, during menstrual periods

If you understand what triggers your attacks, you may be able to prevent migraine attacks or reduce their frequency. Keeping a headache diary will help you identify and monitor all of the possible migraine triggers you encounter. Once the triggers are identified, you and your doctor can modify your treatment and lifestyle appropriately.

Ask your doctor if you have any questions about why MAXALT has been prescribed for you.

How MAXALT Wafers work

During a migraine attack, blood vessels in the brain dilate, or widen, resulting in a throbbing pain. MAXALT Wafers decrease this widening, returning the blood vessels to their normal size, and therefore helps to relieve the pain. MAXALT Wafers also block the release of certain chemicals from nerve endings that cause more pain and other symptoms of migraine.

Before you take MAXALT Wafers

When you must not take it

Do not take MAXALT Wafers if you have an allergy to MAXALT or any of the ingredients listed at the end of this leaflet.

Do not take MAXALT Wafers if you have or had:

• high blood pressure that is not being treated
• some heart diseases, including angina, or a previous heart attack
• a stroke or transient ischaemic attack (TIA)
• blood vessel problems, including ischaemic bowel disease

Do not take MAXALT Wafers if you are currently taking monoamine oxidase inhibitors (MAOIs) for depression, or have taken them within the last two weeks. MAOIs include moclobemide, phenelzine, tranylcypromine and pargyline.

Do not take MAXALT Wafers if the packaging is torn or shows signs of tampering.

Do not take MAXALT Wafers if the expiry date on the pack has passed. If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking MAXALT Wafers, talk to your doctor.

Do not give MAXALT Wafers to children under 18 years of age. The safety and effectiveness of MAXALT Wafers in children under 18 years have not been established.

Before you start to take it

Tell your doctor if:

1. you are pregnant or intend to become pregnant

Like most medicines, MAXALT Wafers are not recommended for use during pregnancy. If there is a need to consider MAXALT Wafers during pregnancy, your doctor will discuss with you the risks and benefits of taking them during pregnancy.

2. you are breast-feeding or plan to breast-feed

It is not known whether MAXALT Wafers pass into breast milk. Your doctor will discuss with you the risks and benefits of taking them while breast-feeding.

3. you have any risks factors for heart or blood vessel disease, including:

• high blood pressure
• diabetes
• smoking
• a high cholesterol level
• a family history of heart or blood vessel disease

4. your headache is more severe than your 'usual' migraine, or it behaves differently
5. you have a condition called phenylketonuria

The 5mg wafer* contains 1.05mg phenylalanine (a component of aspartame) and the 10mg wafer contains 2.10mg phenylalanine.

6. you have, or have had, any other medical conditions
7. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any MAXALT Wafers.

Taking other medicines

Tell your doctor if you are taking any other medicines, herbal products, or dietary supplements, including those that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines should not be taken with MAXALT Wafers. These include:

• monoamine oxidase inhibitors (MAOIs) used to treat depression, including moclobemide, tranylcypromine, phenelzine, pargyline
• sumatriptan, another similar medicine used to treat migraine

Some medicines, herbal products, or dietary supplements, and MAXALT Wafers may interfere with each other. These include:

• propranolol, a medicine used to treat high blood pressure
• ergotamine, dihydroergotamine, other medicines used to treat migraine
• methysergide, a medicine used to prevent migraine
• St. John's wort (Hypericum perforatum), a herbal product sold as a dietary supplement, or products containing St. John's wort

These medicines, herbal products, or dietary supplements may be affected by MAXALT Wafers, or may affect how well it works. You may need different amounts of your medicine, you may need to take different medicines or you may need to be careful of the timing of some of these medicines.

Ask your doctor for instructions about taking MAXALT Wafers if you are also taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking MAXALT Wafers.

How to take MAXALT Wafers

How much to take

Take MAXALT Wafers only when prescribed by your doctor.

The usual dose to treat a migraine is one 10 mg wafer.

If the first MAXALT Wafer does help your migraine, but it comes back later, you may take another wafer.

Take the second wafer at least 2 hours after the first. Do not take more than 30 mg (three 10 mg wafers) in a 24 hour period.

If the first MAXALT Wafer does not help your migraine, do not take another wafer for the same attack as it is unlikely to help. It is still likely, however, that you will respond to MAXALT during your next attack.

You should not take MAXALT 10mg while you are taking propranolol.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How to take it

With dry hands place the wafer on your tongue. The wafer will dissolve rapidly and be swallowed with your saliva. No water is needed for taking the wafer.

It does not matter if you take MAXALT Wafers before or after food.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too many MAXALT Wafers. Do this even if there are no signs of discomfort or poisoning.

If you take too many wafers, you may feel sleepy, dizzy, faint or have a slow heart beat.

While you are using MAXALT Wafers

Things you must do

If your headache is more severe than your 'usual' migraine or it behaves differently, tell your doctor.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you take MAXALT Wafers for migraines.

If you become pregnant while taking MAXALT Wafers, tell your doctor immediately.

Things you must not do

Do not give MAXALT Wafers to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how MAXALT Wafers affect you. Migraine or treatment with MAXALT Wafers may cause sleepiness or dizziness in some people. Make sure you know how you react to MAXALT Wafers before you drive a car, operate machinery, or do anything else that could be dangerous if you are sleepy or dizzy. If you drink alcohol, sleepiness or dizziness may be worse.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MAXALT Wafers.

MAXALT Wafers help most people with migraine headaches, but they may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

1. difficulty thinking or working because of:

• sleepiness, tiredness
• dizziness
• inability to sleep
• decreased mental sharpness
• nervousness
• agitation
• seeing/ feeling/ hearing things that are not there
• headache not relieved by MAXALT

2. stomach or bowel problems

• feeling sick (nausea), vomiting
• stomach upset or pain
• diarrhoea

3. changes in your sight or taste such as:

• blurred vision
• dry mouth
• thirst
• bad taste
• throat discomfort
• tongue swelling

4. skin problems

• skin rash, itching
• redness or flushing of the face
• hot flushes, sweating

5. changes in the way your body feels, such as:

• feelings of heaviness or tightness on parts of the body
• muscle weakness
• muscle pain
• tingling or numbness of the hands or feet
• tremor, unsteadiness when walking
• spinning sensation, also called vertigo
• very high temperature
• unusually increased reflexes or lack of coordination

6. fast, slow or irregular heart beats, palpitations
7. neck pain or facial pain

Dizziness, sleepiness and tiredness are the most common side effects of MAXALT Wafers. For the most part, these have been mild.

Abnormalities of the electrocardiogram (a test that records the electrical activity of your heart) have also been reported.

If you take MAXALT Wafers too often, you may get chronic headaches. Contact your doctor as you may have to stop taking MAXALT Wafers.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

• fainting, coma
• pinkish, itchy swellings on the skin, also called hives or nettlerash
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• shortness of breath, wheezing
• pain or tightness in chest (which may be symptoms of heart attack or angina)
• collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech (which may be symptoms of stroke)
• severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell.
• seizures, fits or convulsions
• persistent purple discolouration, and/or pain in the fingers, toes, ears, nose or jaw
• pain or spasms in the lower stomach, bloody diarrhoea and fever

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

As with other medicines in the same class as MAXALT, heart attack, angina and stroke have been reported very rarely, and generally occurred in people with risk factors for heart or blood vessel disease (including high blood pressure, diabetes, smoking, family history of heart or blood vessel disease e.g. stroke).

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using MAXALT Wafers

Storage

Keep your blister containing each individual wafer in the aluminium sachet until it is time to take it. Each wafer is packed in a blister within an outer aluminium sachet. If you take the wafer out of the blister and PVC/PVDC/Al sachet, it may not keep well.

Keep MAXALT Wafers in a cool dry place where the temperature stays below 30°C. Do not store them or any other medicine in the bathroom or near a sink.

Do not leave them in the car or on window sills. Heat and dampness can destroy some medicines.

Keep them where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the wafers, or the wafers have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

MAXALT Wafers are available in two strengths:

MAXALT Wafers 5mg* - a white to off-white round wafer with a flat or slightly irregular surface.

A pack contains 2, 3 or 6 wafers*.

MAXALT Wafers 10mg - a white to off-white round wafer with a flat or slightly irregular surface.

A pack contains 2, 3* or 6* wafers. A starter pack containing 1 MAXALT 10 mg wafer is also available.

Ingredients

Active ingredient:

• MAXALT Wafers 5mg* - 7.265mg rizatriptan benzoate per wafer, equivalent to 5 mg rizatriptan
• MAXALT Wafers 10mg - 14.53mg rizatriptan benzoate per wafer, equivalent to 10mg rizatriptan

Inactive ingredients:

• gelatin
• mannitol
• glycine
• aspartame
• Peppermint NAEFCO P0551 957685 (ARTG ID: 2890

MAXALT Wafers do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

MAXALT Wafers are supplied in Australia by:

Organon Pharma Pty Ltd
Building A, 26 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in January 2021.

This CMI leaflet was current at the time of printing. To check if it has been updated, please visit our website, www.msd-australia.com.au, or ask your pharmacist.

Australian Register Number:
5 mg - AUST R 69077*
10 mg - AUST R 69076

* Not currently marketed in Australia.

Published by MIMS March 2021

1 Name of Medicine

Rizatriptan benzoate.

2 Qualitative and Quantitative Composition

Rizatriptan benzoate is a white to off white, crystalline solid. Rizatriptan benzoate is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.
Each lyophilised wafer contains either 7.265 mg or 14.53 mg of rizatriptan benzoate (corresponding to 5 mg or 10 mg of rizatriptan, respectively).

List of excipients with known effect.

3 Pharmaceutical Form

5 mg wafer.

10 mg wafer.

4 Clinical Particulars

4.1 Therapeutic Indications

Maxalt is indicated for the acute treatment of migraine attacks with or without aura.

4.2 Dose and Method of Administration

Maxalt wafers are rapidly dissolving wafers. Administration with liquid is not necessary.
The wafer is packaged in a blister within an outer aluminium sachet (pouch). Patients should be instructed not to remove the blister from the outer sachet until just prior to dosing. The blister pack should then be peeled open with dry hands and the wafer placed on the tongue, where it will dissolve and be swallowed with the saliva.
The recommended dose is 10 mg. Clinical experience has shown that this dose provides the optimal clinical benefit.
Onset of relief (i.e. reduction of headache pain to mild or none) can occur within 30 minutes after dosing.

Redosing.

For headache recurrence within 24 hours.

After nonresponse.

Patients receiving propranolol.

4.3 Contraindications

Maxalt is contraindicated in patients with:
hypersensitivity to rizatriptan or any of the ingredients;
concurrent administration of monoamine oxidase (MAO) inhibitors, or use within 2 weeks of discontinuation of MAO inhibitor therapy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Based on the mechanism of action of this class of compounds, Maxalt is also contraindicated in patients with:
uncontrolled hypertension;
established coronary artery disease, including ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), signs and symptoms of ischemic heart disease, or Prinzmetal's angina;
history of stroke or transient ischemic attack (TIA);
peripheral vascular disease, including (but not limited to) ischemic bowel disease.

4.4 Special Warnings and Precautions for Use

Maxalt should only be administered to patients in whom a clear diagnosis of migraine has been established. Maxalt should not be administered to patients with basilar or hemiplegic migraine.
Maxalt should not be used to treat 'atypical' headaches, i.e. those that might be associated with potentially serious medical conditions (e.g. stroke, ruptured aneurysm) in which cerebrovascular vasoconstriction could be harmful.
There have been rare reports of serious coronary events with this class of drugs including Maxalt (see Section 4.8 Adverse Effects (Undesirable Effects)). Prior to prescribing this drug, cardiovascular assessment should be considered in patients at risk for coronary artery disease (CAD) [e.g. patients with hypertension, diabetics, smokers, and those with strong family history for CAD]. Those in whom CAD is established should not be given Maxalt (see Section 4.3 Contraindications).
Other 5-HT_1B/1D agonists (e.g. sumatriptan) should not be used concomitantly with Maxalt.
Administration of ergotamine type medications (e.g. ergotamine, dihydroergotamine or methysergide) and Maxalt within 6 hours of each other is not recommended. Although additive vasospastic effects were not observed in a clinical pharmacology study in which 16 healthy males received oral rizatriptan and parenteral ergotamine, such additive effects are theoretically possible.
Cases of life threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans. If concomitant treatment with Maxalt and an SSRI (e.g. sertraline, escitalopram oxalate, and fluoxetine) or SNRI (e.g. venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Use by gender or in individuals of various ethnic origins.

Phenylketonurics.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Children (under 12 years of age).

Adolescents (12-17 years of age).

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacokinetic interactions.

Cytochrome P450 isoforms.

Monoamine oxidase inhibitors.

Beta-blockers.

Selective serotonin reuptake inhibitors/ serotonin norepinephrine reuptake inhibitors and serotonin syndrome.

Paroxetine.

Oral contraceptives.

Experience in migraine patients.

St John's wort (Hypericum perforatum).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Migraine or treatment with Maxalt may cause somnolence in some patients. Dizziness has also been reported in some patients receiving Maxalt. Patients should, therefore, evaluate their ability to perform complex tasks during migraine attacks and after administration of Maxalt.

4.8 Adverse Effects (Undesirable Effects)

Adverse experiences were assessed in controlled clinical trials in which over 3,600 patients received single or multiple doses of Maxalt as the tablet and wafer formulation. More than 1,500 patients were treated in long-term extension studies for up to one year.
In clinical trials, Maxalt was generally well tolerated. Adverse experiences were typically mild in intensity and transient. The most common drug related adverse experiences were dizziness, somnolence, and asthenia/ fatigue. Table 1 lists drug related adverse experiences in acute phase III trials in outpatients with migraine.
Additional drug related adverse experiences in patients taking 1 or more doses of Maxalt 5 mg or 10 mg during acute (incidence ≥ 1% and greater than placebo) or long-term (incidence ≥ 1%) clinical trials were, by body system.

Body as a whole.

Cardiovascular.

Digestive.

Musculoskeletal.

Nervous system.

Respiratory.

Skin.

Special senses.

Urogenital.

Postmarketing experience.

Hypersensitivity.

Musculoskeletal.

Special senses.

Nervous system.

Vascular disorders.

Cardiac disorders.

Gastrointestinal disorders.

Investigations.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).
No overdoses of Maxalt were reported during clinical trials.
Rizatriptan 40 mg (administered as either a single dose or as two doses with a 2 hour interdose interval) was generally well tolerated in over 300 patients; dizziness and somnolence were the most common drug related adverse effects.
In a clinical pharmacology study in which 12 subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. One subject, a female aged 29 years, developed vomiting, bradycardia, and dizziness beginning three hours after receiving a total of 80 mg rizatriptan (administered over two hours). A third degree AV block, responsive to atropine, was observed an hour after the onset of the other symptoms. The second subject, a 25 year old male, experienced transient dizziness, syncope, incontinence, and a 5 second systolic pause (on ECG monitor) immediately after a painful venipuncture. The venipuncture occurred two hours after the subject had received a total of 80 mg rizatriptan (administered over four hours).
In addition, based on the pharmacology of rizatriptan, hypertension or other more serious cardiovascular symptoms could occur after overdosage. Gastrointestinal decontamination (e.g. gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with Maxalt. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of haemo or peritoneal dialysis on serum concentrations of rizatriptan are unknown.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacodynamics.

Clinical trials.

Maxalt tablets.

Maxalt wafers.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Characteristics in patients.

Gender.

Elderly.

Hepatic impairment.

Renal impairment.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each lyophilised wafer contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and Peppermint NAEFCO P0551 957685 (ARTG ID: 2890).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The expiry date can be found on the packaging. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

6.4 Special Precautions for Storage

Store at room temperature below 30°C. For the wafer, the patient should be instructed not to remove the blister from the outer aluminium sachet until the patient is ready to consume the wafer inside.

6.5 Nature and Contents of Container

5 mg wafer - Supplied in packs of 2, 3 or 6 wafers.^#
10 mg wafer - Supplied in a starter pack of 1 wafer (sample pack only not for sale), and trade packs of 2, 3^# or 6^# wafers.
^#Presentation not currently marketed in Australia.
Maxalt wafers are available in PVC/PVDC/Al blisters.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate.
Its empirical formula is C₁₅H₁₉N₅.C₇H₆O₂.
The molecular weight of the benzoate salt is 391.47; the molecular weight of the free base is 269.4.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes